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OpenTrials
Completed

NCT Number: NCT05173571

Homecare Integral Support Program for IPF Patients

Homecare patient support program especially designed for covering IPF patient needs, implemented for 12 months, for improving quality of life

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IDIBELL. University Hospital of Bellvitge

L'Hospitalet de Llobregat, Spain

About this study

The proposed comprehensive IPF home care programme consists of: 1) improving patient's quality of life (autonomy, activity, emotional well-being and symptoms), 2) reducing the number and severity of side effects associated with the anti-fibrotic drug, 3) reducing the number of hospitalisations attributable to the disease, and 4) providing a rapid response to any problem associated with the disease (after diagnosis or progression) that may cause distress or require early action.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • IPF patients with FVC > 50% and DLCO > 30%, in whom pharmacological treatment with nintedanib was started at least one month before the start of the programme.

Exclusion criteria

  • Hospitalised patients or those who have been hospitalised in the previous month, due to any kind of respiratory exacerbation or due to any other respiratory cause.
  • Patients who are under home care controls (PADES) as this implies an advanced stage of the disease (forced vital capacity [FVC] less than 50% and the diffusion capacity of the lungs for carbon monoxide [DLCO] less than 30%) or, patients thathave a lack of autonomy due to comorbidities or respiratory failure
  • Patients diagnosed in incipient phase who have neither symptoms nor limitation in their usual activities.
  • Patients who have suffered any other life-threatening disease in the last 2 years, such as cancer or uncontrolled ischaemic heart disease.
  • Inability to understand the information given to the patient, relating to the legal aspects of the informed consent.

Treatment and study plan

Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)

Combination Product

Identification of patient needs and non-pharmacological holistic approach, including education, emotion and nutrition (nurse) and optimization of physical activity (respiratory physiotherapist)

Other names: Nurse and Respiratory Physiotherapist holistic plan

Primary outcomes

  1. Qulity of life

    Time frame: 12 months

    K-BILD score (global and by domains)

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Bellvitge

Other

Registry information

Official study title

Home Comprehensive Therapeutic Support Program in Patients With Pulmonary Fibrosis

Acronym: PSPi-IPF

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Dec 30, 2021
Registry last updated
Dec 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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